Gas-saline dispensing ampule

ABSTRACT

A glass ampule for storing and dispensing radioactive gas-saline solution mixture comprising an elongated neck for storing saline, a bulb attached to the neck for storing gas at sub-atmospheric pressure and an inverted conical glass seal at the proximate intersection between neck and bulb for keeping the materials separate until use. A tapping needle inserted through a gasket disc at the free end is used to rupture the glass seal thereby allowing mixing to occur and subsequent removal by volume displacement into a syringe attached to the tapping needle.

O United States Patent 1191 1111 3,821,955 Carroll July 2, 1974 GAS-SALINE DISPENSING AMPULE 3,081,029 3/1963 Gauslaa 128/272 x Y Inventor: Robert G- a m t s g Pa. 3,462,245 8/1959 lisdes et 1:1. 128/ 1.1 X

[73] Assigne e: The United States of America as FOREIGN ATE TS O APPLICATIONS represented the of 451,]70 8/1943 Canada 206/47 A De artment of Health Ed ti d wgfare, Washington on an Primary Examinerfistanley H. Tollberg [22] F d M 29 1972 Assistant Examiner-Larry Martin 1e ar. I

[21] Appl. No.: 239,197 1 7 B TRA A glass ampule for storing and dispensing radioactive gas-saline solution mixture comprising an elongated 128/272 neck for storing saline, a bulb attached to the neck for [58] Fie'ld 12 storing gas at sub-atmospheric pressure and an in- I. vetted conical glass seal at the proximate intersection between neck and bulb for keeping the materials sepahrou h a [56] keferencesclted rate unt l use. A tappmg needlemserted t g g gasket d1sc at the free end 1s used to rupture the glass 1 UNITED STATES PATENTS seal thereby allowing mixing to occur and subsequent removal by volume displacement into a syringe at- 6U em... 1,674,928 6/1928 Smith 128/272 tached to the tapping i 1,928,998 10/1933 Kovacs 128/272 7 Claims, 2 Drawing Figures iifi'iiiilfi XENON FILLING TUBE 30 I CHAMBER SALINE-FILLED 35 NECK 33 NM 34 ,.u\a \\\v\v\u\mr\s i 'l'- ';'-'i 'i :j":'= i 38 l:.. \a\ \\\\\|ws\\s 5 INVERTED CONE GLASS BREAK SEAL GAS-SALINE DISPENSING AMPULE FIELD OF THE INVENTION This invention relates generally to mixing ampules having multiple compartments, and, more particularly, to ampules having a first compartment containing gas, an adjacent compartment containing liquid, with a rupturable wall between compartments which is broken for mixing the contents in each compartment.

BACKGROUND OF THE INVENTION Glass ampules are well known for dispensing predetermined concentrations of decomposable medicaments, radioactive gases and the like. Thus, for example, in US. Pat. No. 1,674,927 issued to A. E. Smith on June 26, 1928, an ampule is described having one compartment under vacuum which is partially filled with a.

cated in one compartment. The gaseous decay products mix with an absorbing liquid in another compartment when the seal separating the two compartments is broken. The radioactive solution is dispensed through an open glass nozzle projecting from the dispensing compartment.

Although the ampules described hereinabove-appear to be satisfactory for dispensing solids or liquids, they are not particularly well suited for dispensing gases which may be insoluble or only slightly soluble in liquids. Nor are these conventional ampules suitable for dispensing gases at different intervals since the containers are not designed to'store gas contents after once being dispensed. Upon exposure to the atmosphere the gas left in the ampule would readily escape therefrom. Where the gasis radioactive, a safety problem could arise were the venting to occur in a confined area.

The standard Oak Ridge glass radioactive gas ampule, for equilibration of the gas with a liquid such as I saline solution, has two chambers and a seal therebetween, as well as a terminal neck portion for insertion of a seal breaking device. However, the seal does not provide for the trapping of a bubble within the ampule bulb, it does not provide for guiding of the tap needle, and stresses occur at the bulb-neck joint during insertion of the tap needle. In addition, the end of the neck provides excessive contact between the rubber seal located at this point and the xenon saline solution therewithin and there is insufficient neck endisealing. Excessive concentration of radioactive gas in saline or as a bubble may come in contact with the sealand thus escape.

SUMMARY OF THE INVENTION It is, therefore, an object of the invention to overcome the deficiencies of the prior art, such as indicated above.

It is another object of the present invention to provide a multi-compartment glass ampule for storing and dispensing gases, especially radioactive gases, which avoid the drawbacks of prior devices.

Another object of the present invention is to provide an ampule for producing a radioactive Xenon-saline solution including a separate compartment functioning as an equilibration chamber.

Another object of the present invention is to provide an ampule with self-sealing means to enable the dispensing of predetermined dosages all at once, or over a period of time, without contaminating or losing the ampule contents.

Still another object of the present invention is to provide an ampule having a rupturable internal seal of substantially conical configuration which separates adjacent ampule compartments.

A further object of the present invention is to provide an ampule which is economic in construction and permits trouble-free dispensing of saline solution equilibrated with radioactive gases in dosage quantities by liquid displacement technique;

These and'other objects of the present invention are achieved by providing an ampule comprising an elongated neck portion which holds the liquid, the lower end of which terminates at a hollow bulb portion which initially contains the gas and the latter serves as an equilibration chamber for the gas-liquid mixture. The upper end of the neck terminates at a flange which is overcapped with a metal cap having a self-sealing closure therein. Internally, at the proximate intersection betweenneck and bulb portions an inverted conical.

seal is provided to separate the neck portion contents from the bulb contents until use is contemplated and minimize the concentration of Xenon adjacent to the rubber seal. Thus, the bulb is isolated from the rubber seal by interposition of the neck portion.

As earlier mentioned, the neck portion is filled with liquid, such as a saline solution, the lower bulb portions havingbeen earlier filled with a suitable gas, such as a radioactive gas, preferably Xenon, which is to be mixed with the liquid thereabove. To mix the contents of each compartment of the ampule a tap needle is inserted through the flange gasket, or self-sealing disc, into the neck portion through the liquid in the neck. The inverted conical seal is broken and the liquid and gas mix and equilibrate. Dosage portions can be withdrawn whenever desired by displacing the liquid equilibrated with gas in the bulb with further addition of liquid via a second needle disposed adjacent the tap needle in the neck portion.

The ampule neck terminates in a broad flange which has a central opening of a size sufficient for insertions of the supply and tapping needles only. The flange outer diameter provides a good support for capping with conventional metal capping equipment; this provides for maximum cap sealing area.

Some additional significant advantages of the present invention are as follows:

The ampule is substantially all glass or the like with minimum rubber in contact with the dispensing. solution, thus minimizing possible loss of radioactive gas which tends to dissolve into and diffuse through the rubber;

The seal between the ampule bulb and neck is in the form of an inverted cone pointing into the ampule bulb, permitting positive trapping of a bubble withinthe ampule bulb, positive guiding of the tap needle, and a reduced stress at bulbneck joint during insertion of the tap needle.

Another important advantage resides in the troublefree manner in which equilibrated gas/fluid dosages are recovered from the ampule for administration, without storage or processing losses of radioactive gasses.

Thus, it will be appreciated from the drawing and the description which follows that the ampule according to the present invention represents a much improved device for dispensing radioactive gas-saline solutions in predetermined dosages.

The device can be used in conjunction with any radioactive gas such as any of the known radioactive isotopes of gases such as krypton, Xenon, Hydrogen or the like. Examples include Krypton and Xenon and "Xenon. The device can also be used in conjunction with any suitable carrier liquid which can be mixed with the radioactive gas. Such a carrier liquid is preferably a standard aqueous saline solution, e.g., sodium chloride. However, any other known parenteral aqueous solution can be used in accordancewith known practice.

BRIEF DESCRIPTION OF THE DRAWING For a better understanding of the invention a possible embodiment thereof will be described with reference to the attached drawing wherein like numerals indicate like elements throughout the several views, it being understood that this embodiment is exemplary and not limitative. v I

FIG. 1 is a diagrammatic sketch in sectional view illustrating an ampule according to the present invention; and

FIG. 2 illustrates the ampule of FIG. 1 in position for withdrawing the mixed contents therefrom, also showing auxiliary equipment employed in the withdrawal.

DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIG. I, there is illustrated a glass ampule in accordance with the present invention. The ampule 10 includes an elongated generally cylindrical neck portion 12, the free end of which terminates at a widened flange 14. A hollow bulb portion 16 is joined to the neck portion 12 at the joint 18, adjacent the other end of the neck 12. As illustrated, the neck end 20 projects into the volume occupied by the bulb 16; however, it will be understood that the end 20 could terminate at the junction 18, if desired.

Inside the bulb 16, adjacent the proximate intersec tion 18 between the neck portion 12 and the bulb 16,

I an inverted conical-like frangible seal 22 is provided at the terminal end 24 of the neck portion 12. A tapered section 26 having a slightly constructed opening 28 is coincidentially affixed between the neck end 20 and the conical seal 22. The diameter of the constricted opening 28 is sufficiently large to permit passage of a tapping needle and yet small enough to also guide the needle into the bulb 16 as will become more apparent hereinafter.

The bulb portion 16 is also preferably of glass construction and is of sufficient volume to hold a predetermined quality of radioactive gas in equilibrium with a predetermined amount of saline solution. The bulb 16 can be of any desired shape such as cylindrical, spherical or the like.

An elongated hollowtube 30, shown in FIG. 1 in phantom, is initially attached to the bulb to permit evacuation of the initially present air in the bulb and the subsequent filling of the evacuated space with radioactive gas. The technique for filling the bulb with radioactive gas is conventional and is not considered a part of this invention. After the bulb 16 is filled with radioactive Xenon (i.e., Xenon), the filling tube 30 is closed by fusing at the base portion 32. The remainder of the tube can then be severed and discarded.

In order to expedite the later introduction of saline solution from the neck portion 12 into the bulb portion 16, the gas pressure in the bulb portion is generally less than the pressure of saline solution and preferably less than atmospheric pressure. This insures liquid flow into the bulb when the seal 22 is broken.

To complete the ampule 10 according to the present invention the neck portion 12 is filled with a saline solution 33 and then capped in a conventional manner. The ampule 10 is then ready for immediate use or may be stored until such time as its use is required.

The flange 14 at the free end of the neck portion 12 is designated to receive a conventional metal cap 34 of the type which can be crimped over the underside of the flange 14, as indicated at 36. Aluminum is the preferred cap material although'other metals or plastics can be substituted. A central cap opening 38 permits the introduction of a needle through a suitable gasket 40 into the neck portion 12. The gasket 40 is positioned on the inside of the cap 34 for sealing the flanges 14 and can be of any well known inert elastomeric material having self-sealing properties, such as rubber, or tet'rafluoroethylene polymer lined rubber, or Viton is preferred.

FIG. 2 illustrates the ampule 10 of the present invention secured in a fixture 42, such as a radioactive shield, in preparation for use. The fixture 42 includes an inner chamber 44 adapted to receive the ampule 10. At the entrance of the chamber a movable collar 46 is provided which secures the neck portion of the ampule 10 to permit the insertion of one or more needles as will be described in greater detail hereinbelow. v

In order to produce Xenon saline solution, the neck 12 is filled with saline to the exclusion of any bubbles. This may be done in manufacture or by the user.

a A saline primed tap unit 50 comprises a syringe 51, a

large long needle 52 attached to a Millipore filter 54 and a stopcock 56. The needle 52 is advanced through the rubber gasket 40 and into the neck portion 12 of the ampule 10. A small needle attached to a oneway valve 62 and saline filled syringe '64 is also advanced through the rubber gasket 40. The long tap needle 52 is thrust through the conical glass seal 22 into the ampule bulb 16 containing Xenon gas at less than atmospheric pressure. Saline is injected through the one-way valve 62 into the neck 12, thereby forcing saline into the bulb 16 where it equilibrates with the radioactive gas. The gas bubble is trapped within the bulb l0, and, therefore, cannot enter the neck 12 to contact the gasket seal 40.

Patient doses are withdrawn by the syringe 51, attached to the tap unit by volume displacement resulting from injection of additional saline through the one way valve 62. This unidirectional saline flow tends to minimize the concentration of radioactive gas solution adjacent to the rubber gasket 40, thus minimizing loss of the gas into and through the rubber seal. It will be appreciated that one of the principal uses of the present invention is its use with any sparingly soluble radioactive or non-radioactive gas. It can also be used simply as a gas dispenser through volume displacement with another gas.

It should be appreciated that the present invention is not to be construed as being limited by the illustrative embodiments. lt is possible to produce still other embodiments without departing from the inventive concept herein disclosed. Such embodiments are within the ability of one skilled in the art.

What is claimed is: 1. A gas-saline ampule for storing and dispensing saturated solutions of a poorly soluble radioactive gas in a salt solution, comprising equilibration chamber means (a) to initially store a radioactive gas under subatmospheric pressure and (b) to subsequently equilibrate and store a mixture of said radioactive gas and said salt solution;

means to isolate said equilibration'chamber, said iso lation means comprising a second chamber in the form of an elongated generally cylindrical neck having an inside diameter sufficiently large to permit av tapping needle to pass therethrough and initially containing said salt solution, said elongated neck having a first end and a second end and being joined to said equilibration chamber adjacent said first end, said elongated neck providing the only entrance to said equilibration chamber;

self-sealing means to close said elongated neck and to dispense therethrough predetermined dosages of said mixture without contamination or loss thereof, said self-sealing means being located at the second end of said elongated neck; and

frangible sealing and needle guiding means at said first end of said elongated neck and being generally conical toward the interior of said equilibration chamber, said frangible sealing and needle guiding means initially separating said equilibration chamber from said elongated neck.

2. The ampule according to claim 1 wherein said sec ond end of said elongated neck comprises a widened flange, and said self-sealing means comprises a deformable cap having an internally positioned self-sealing disc, said cap being crimped over said flange to provide a leak-tight construction.

3. The ampule according to claim 1 wherein said frangible sealing and guiding means comprises a substantially inverted conical member of glass construction.

4. The ampule according to claim 3 wherein said substantially inverted conical member is attached to said neck portion and located within equilibration chamber cavity at the proximate intersection between said bulb and said neck.

5. The ampule according to claim 4 further including a tapered section between said conical member and said neck portion.

6. The ampule according to claim 1 further comprising shield means for surrounding said ampule, a long tap needle passing through said self-sealing means and through said neck and through said conical needle guiding means into said equilibration chamber, a second needle passing through said self-sealing means into said neck, means to feed salt solution into said neck through said second needle, and means to receive equilibrated gas-saline solution mixture from said equilibration chamber through said long tapping needle.

7. The ampule according to claim 6 wherein the radioactive gas is Xenon. 

1. A gas-saline ampule for storing and dispensing saturated solutions of a poorly soluble radioactive gas in a salt solution, comprising equilibration chamber means (a) to initially store a radioactive gas under subatmospheric pressure and (b) to subsequently equilibrate and store a mixture of said radioactive gas and said salt solution; means to isolate said equilibration chamber, said isolation means comprising a second chamber in the form of an elongated generally cylindrical neck having an inside diameter sufficiently large to permit a tapping needle to pass therethrough and initially containing said salt solution, said elongated neck having a first end and a second end and being joined to said equilibration chamber adjacent said first end, said elongated neck providing the only entrance to said equilibration chamber; self-sealing means to close said elongated neck and to dispense therethrough predetermined dosages of said mixTure without contamination or loss thereof, said self-sealing means being located at the second end of said elongated neck; and frangible sealing and needle guiding means at said first end of said elongated neck and being generally conical toward the interior of said equilibration chamber, said frangible sealing and needle guiding means initially separating said equilibration chamber from said elongated neck.
 2. The ampule according to claim 1 wherein said second end of said elongated neck comprises a widened flange, and said self-sealing means comprises a deformable cap having an internally positioned self-sealing disc, said cap being crimped over said flange to provide a leak-tight construction.
 3. The ampule according to claim 1 wherein said frangible sealing and guiding means comprises a substantially inverted conical member of glass construction.
 4. The ampule according to claim 3 wherein said substantially inverted conical member is attached to said neck portion and located within equilibration chamber cavity at the proximate intersection between said bulb and said neck.
 5. The ampule according to claim 4 further including a tapered section between said conical member and said neck portion.
 6. The ampule according to claim 1 further comprising shield means for surrounding said ampule, a long tap needle passing through said self-sealing means and through said neck and through said conical needle guiding means into said equilibration chamber, a second needle passing through said self-sealing means into said neck, means to feed salt solution into said neck through said second needle, and means to receive equilibrated gas-saline solution mixture from said equilibration chamber through said long tapping needle.
 7. The ampule according to claim 6 wherein the radioactive gas is 133Xenon. 